Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Andrea Szelenyi, MD PhD

Michael Sabel, MD PhD

Jan Vesper, MD PhD

Stefan Schu, MD

Lutz Weise, MD

During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function. For this muscle motor evoked potentials are used. Those are elicited by transcranial and direct cortical stimulation. Motor responses are recorded from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord. This is called spinal motor evoked potentials. It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors. This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials. With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.

Spinal Motor Evoked Potentials in Brain Surgery

Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region

numeric assessment, amplitude and latency of D-wave

clinical motor status according to the MRC scheme

Johann Wolfgang Goethe University Hospital

Heinrich-Heine University, Duesseldorf

Professor

Immune System Diseases

Hypersensitivity

The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored.

Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

cCeLL - Ex vivo

Kyungmin Hwang

Heejoon Um

Sunit Das, PhD, MA, BA

Sunit Das, MD, PhD, MA, BA

Shin-Hyuk Kang, MD, M.M.Sc, PhD

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question\[s\] it aims to answer are:

* Is it as accurate as standard biopsy practices?
* Can it be performed faster than standard biopsy practices?

Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.

The usual practice for imaging brain tumor tissue during this type of operation, is to remove tissue from a suspicious lesion and send the tissue to the pathology department where pathologists perform a test called "frozen section". The frozen section test cools the tissue to give a diagnosis of the tissue sample (e.g., cancerous or normal tissue). This process may take up to 40 minutes to perform and uses a lot of resources within the hospital. The operation can only be finished after this report is available to the surgeon. After the surgery, the tissue is assessed by pathology with a test called permanent section which can give more details about the tissue assessment. Permanent section results are not available until after the surgery is complete. VPIX Medical Inc. has developed a system to image brain tumor tissue for the purpose of making a diagnosis (clinical decision) during the operation. This system uses Confocal Laser Endomicroscopy to image the removed tissue during the operation. This may be able to replace current standard 'frozen section analysis', which would decrease the resources needed to image the tissue, and provide faster results to the surgeon during the operation. The investigators are performing this study to determine if this type of imaging is as accurate as frozen section and if it can be performed faster. The tissue samples that are being assessed by the study device will be removed as part of a participant's normal surgery. This study will compare the results of the study device and the frozen section results. During the participant's surgery, only the standard test results will be used to make decisions. The images generated by cCeLL device will also be stored in a secure server outside of Canada, for the duration of the study. These images will be de-identified to protect participant privacy, and will be used to create a scientific repository.

cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the Proposed Cell/Tissue Histopathology Image Processor cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Agreement between cCeLL - Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo.

Time from the beginning of imaging to the completion of analysis

Time required by the blinded assessor reach a diagnosis.

Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken

Number of images required by the blinded assessor reach a diagnosis.

Unity Health Toronto

Korea University Anam Hospital

Samsung Medical Center

Seoul National University Hospital

VPIX Medical

adult patients undergoing brain tumor surgery

Calculated nutritional index using laboratory results of serum albumin, lymphocyte count, and cholesterol

prognostic nutritional index calculated from laboratory parameters

Youn Joung Cho, MD, PhD

There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. However, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.

In this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.

Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery

Odds ratio of prognostic nutritional index for postoperative mortality

Odds ratio of prognostic nutritional index for postoperative acute kidney injury

Odds ratio of prognostic nutritional index for postoperative renal replacement therapy

Odds ratio of prognostic nutritional index for length of hospital stay

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spinal Motor Evoked Potentials in Brain Surgery	NCT02402075	Brain Tumor Glioma		18 Years -	Heinrich-Heine University, Duesseldorf
cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis	NCT06098248	Benign Brain Tu... Malignant Brain...	cCeLL - Ex vivo	19 Years -	VPIX Medical
Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery	NCT05373836	Clinical Outcom...	prognostic nutr...	20 Years -	Seoul National University Hospital
Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery	NCT05373836	Clinical Outcom...	prognostic nutr...	20 Years -	Seoul National University Hospital

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